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Medical Device Reporting for Manufacturers, March 1997.

PB99105421

Publication Date	1997
Page Count	52
Abstract	This guidance document describes the new Medical Device Reporting requirements for manufacturers. It is intended for both domestic and foreign medical device manufacturers, and is based on the Medical Device Reporting (MDR) requirement published in the final rule dated December 11, 1995. The MDR regulation provides a mechanism for FDA to identify and monitor significant adverse event involving medical devices, so that problems may be detected and corrected in a timely manner. The purpose of the document is to provide domestic and foreign manufacturers with: a thorough description of the current MDR regulation; a clear description of the current MDR regulation; a clear understanding of their reporting responsibilities; guidance to help in the completion of the MDR forms; an overview of required written MDR procedures, records and files; and information on sources for forms, instructions, and other MDR information.
Keywords	Manufacturers Safety Effectiveness Labeling Requirements Regulations Forms Instructions Medical device reporting Food and Drug Administration(FDA)
Source Agency	Center for Devices and Radiological Health
Corporate Authors	Food and Drug Administration, Rockville, MD. Center for Devices and Radiological Health.
Supplemental Notes	See also Draft Report, PB96-175211.
Document Type	Technical Report
NTIS Issue Number	199902

Medical Device Reporting for Manufacturers, March 1997.

Medical Device Reporting for Manufacturers, March 1997.
PB99105421

Publication Date	1997
Page Count	52
Abstract	This guidance document describes the new Medical Device Reporting requirements for manufacturers. It is intended for both domestic and foreign medical device manufacturers, and is based on the Medical Device Reporting (MDR) requirement published in the final rule dated December 11, 1995. The MDR regulation provides a mechanism for FDA to identify and monitor significant adverse event involving medical devices, so that problems may be detected and corrected in a timely manner. The purpose of the document is to provide domestic and foreign manufacturers with: a thorough description of the current MDR regulation; a clear description of the current MDR regulation; a clear understanding of their reporting responsibilities; guidance to help in the completion of the MDR forms; an overview of required written MDR procedures, records and files; and information on sources for forms, instructions, and other MDR information.
Keywords	Manufacturers Safety Effectiveness Labeling Requirements Regulations Forms Instructions Medical device reporting Food and Drug Administration(FDA)
Source Agency	Center for Devices and Radiological Health
Corporate Authors	Food and Drug Administration, Rockville, MD. Center for Devices and Radiological Health.
Supplemental Notes	See also Draft Report, PB96-175211.
Document Type	Technical Report
NTIS Issue Number	199902